JP7584597B2 - Auto-injector with audible indicator - Google Patents

Description

The present disclosure relates generally to drug delivery devices, and more specifically to auto-injectors.

Various types of automatic injection devices have been developed to allow medications and other liquid therapeutic preparations to be administered or self-injected by untrained individuals.

Typically, these devices include a reservoir pre-filled with a liquid therapeutic formulation and some type of automatic needle injection mechanism that can be triggered by the user. Many of these devices, such as auto-injectors, are designed so that a pre-filled reservoir, such as a syringe, is assembled to the device during assembly of the device. In addition to automatically deploying the needle injection mechanism, many drug delivery devices also automatically shield the needle after use of the device to prevent any unintended contact with the needle.

In one aspect, the drug delivery device includes a housing and a syringe assembly including a barrel, a stopper, and a cannula, at least a portion of the syringe assembly disposed within the housing, and a drive assembly including a plunger body configured to move the stopper within the barrel upon actuation of the drive assembly, at least a portion of the drive assembly disposed within the housing. The plunger body has a pre-use position prior to movement of the plunger body, an injection position in which the plunger body moves the stopper within the barrel, and a post-use position in which movement of the plunger body has ceased. The device further includes an audible indicator member configured to provide an audible indication of a transition of the plunger body from the injection position to the post-use position.

The audible indicator member may have a biased position in which the audible indicator member engages a portion of the housing and a released position, with the audible indicator disposed in the biased position when the plunger body is in the injection position and the audible indicator disposed in the released position when the plunger body is in the post-use position. Movement of the audible indicator from the biased position to the released position may result in an audible indication. When the plunger body is in the pre-use position, the audible indicator member may be disposed in the unbiased position. The audible indicator member may engage a portion of the housing to provide an audible indication. The housing may include a lower housing shell, an upper housing shell, and a cassette body received by the lower housing shell, with the lower housing shell including an indicator platform, and the audible indicator member engaging the indicator platform to provide an audible indication.

The housing may include a rib extending longitudinally of the device, the audible indicator member engaging the rib to move the audible indicator member from the unbiased position to the biased position, and the audible indicator member disengaging from the rib to move the audible indicator member from the biased position to the released position to provide an audible indication. The cassette body may include a rib. The rib may include a ramped surface configured to transition the audible indicator member from the unbiased position to the biased position. The rib may extend only a portion of the length of the cassette body. The audible indicator member may be integrally formed with the plunger body.

The device may further include a visual indicator member configured to provide a visual indication of a transition of the plunger body from the injection position to the post-use position. The visual indicator member may be visible through an indicator opening defined by the housing when the plunger body is in the post-use position. The housing may include a lower housing shell, the lower housing shell defining the indicator opening. The visual indicator member may be integrally formed with the plunger body, the visual indicator member being spaced from the audible indicator member.

The drive assembly may further include a drive member configured to bias the plunger body from a pre-use position to an injection position and to a post-use position. The device may further include a pre-use position in which the cannula is disposed within the needle cover, an actuation position in which the needle cover is configured to actuate the drive assembly, and a post-use position in which the cannula is disposed within the needle cover. The device may further include a lever actuation member movable between a locked position in which actuation of the drive assembly is prevented and a released position in which actuation of the drive assembly is permitted, the needle cover engaging the lever actuation member and moving the lever actuation member to the released position when the needle cover is in the actuated position.

The device may further include a syringe holder movable relative to the housing, the syringe assembly being received by the syringe holder. The audible indicator member may be configured to limit movement of the syringe holder when the plunger body is in the pre-use position.

The device may include one or more of the following features, taken individually or in all technically possible combinations:
The drug delivery device may include a syringe assembly including a housing, a barrel, a stopper, and a cannula, at least a portion of the syringe assembly disposed within the housing; a drive assembly including a plunger body configured to move the stopper within the barrel upon actuation of the drive assembly, at least a portion of the drive assembly disposed within the housing, the plunger body having a pre-use position prior to movement of the plunger body, an injection position where the plunger body moves the stopper within the barrel, and a post-use position where movement of the plunger body has stopped; and an audible indicator member configured to provide an audible indication of transition of the plunger body from the injection position to the post-use position.
The audible indicator member may have a biased position in which it engages a portion of the housing and a released position, wherein when the plunger body is in the injection position the audible indicator is disposed in the biased position and when the plunger body is in the post-use position the audible indicator is disposed in the released position, and movement of the audible indicator from the biased position to the released position provides an audible indication.
The audible indicator member may be disposed in an unbiased position when the plunger body is in the pre-use position.
- An audible indicator member may engage a portion of the housing to provide an audible indication.
The housing may include a lower housing shell, an upper housing shell, and a cassette body received by the lower housing shell, the lower housing shell including an indicator platform, and an audible indicator member engaging the indicator platform to provide an audible indication.
- the housing may include ribs extending longitudinally of the device, the audible indicator member engaging the ribs to move the audible indicator member from an unbiased position to a biased position, and the audible indicator member disengaging from the ribs to move the audible indicator from the biased position to a released position to provide an audible indication.
The housing may include a lower housing shell, an upper housing shell, and a cassette body received by the lower housing shell, the cassette body including ribs.
The rib may include a ramp configured to transition the audible indicator member from the unbiased position to the biased position.
The ribs may extend only part of the length of the cassette body.
The audible indicator member may be integrally formed with the plunger body.
The drug delivery device may include a visual indicator member configured to provide a visual indication of the transition of the plunger body from the injection position to the post-use position.
- The visual indicator member is viewable through an indicator opening defined by the housing when the plunger body is in the post-use position.
The housing may include a lower housing shell, the lower housing shell defining a display opening.
- The visual indicator member may be integrally formed with the plunger body, the visual indicator member being spaced apart from the audible indicator member.
The drug delivery device may include a syringe holder movable relative to the housing, the audible indicator member being configured to limit the movement of the syringe holder when the plunger body is in the pre-use position.

The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings.

FIG. 1 is a perspective view of a drug delivery device according to one aspect of the present application, showing a stored position of the device. FIG. 2 is a perspective view of the drug delivery device of FIG. 1, showing the device in a pre-use position. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the device in a stored position. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the device in a pre-use position. FIG. 2 is a perspective view of the drug delivery device of FIG. 1, showing the device in an actuated position. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the device in an actuated position. FIG. 2 is a perspective view of the drug delivery device of FIG. 1, showing the injection position of the device. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the injection position of the device. FIG. 2 is a perspective view of the drug delivery device of FIG. 1, showing the post-use position of the device. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the post-use position of the device. FIG. 2 is a perspective view of the drug delivery device of FIG. 1, showing a locking clip. FIG. 2 is an exploded perspective view of the drug delivery device of FIG. 1, showing a locking clip. FIG. 2 is a partial cross-sectional view of the drug delivery device of FIG. 1, showing the locking arm of the cassette body. FIG. 11B is an enlarged cross-sectional view of the area indicated in FIG. FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1, showing the post-use position of the device prior to complete delivery of the medicament. FIG. 2 is a partial cross-sectional view of the drug delivery device of FIG. 1, illustrating a stored position of the device. FIG. 2 is a perspective view of a lower housing shell of the drug delivery device of FIG. 1 . FIG. 2 is a perspective view of a cassette body of the drug delivery device of FIG. 1 . FIG. 2 is a perspective view of a plunger body of the drug delivery device of FIG. 1 . FIG. 2 is a perspective view of a drug delivery device according to a further aspect of the present application, showing a stored position of the device. 18 is a cross-sectional view taken along line 18-18 shown in FIG. 17. FIG. 18 is a top perspective view of the motor body of the drug delivery device of FIG. 17. FIG. 20 is a bottom perspective view of the motor body of FIG. 19 . FIG. 18 is a front perspective view of the plunger body of the drug delivery device of FIG. FIG. 22 is a rear perspective view of the plunger body of FIG. 21 . FIG. 18 is a front perspective view of a plunger rod portion of the drug delivery device of FIG. FIG. 24 is a rear perspective view of the plunger rod portion of FIG. FIG. 18 is a top perspective view of a lever actuation member of the drug delivery device of FIG. 17 . FIG. 26 is a bottom perspective view of the lever actuation member of the drug delivery device of FIG. 25 . FIG. 18 is a front perspective view of a syringe holder of the drug delivery device of FIG. FIG. 28 is a rear perspective view of the syringe holder of the drug delivery device of FIG. 27. FIG. 18 is a front perspective view of a needle cover of the drug delivery device of FIG. FIG. 30 is a rear perspective view of the needle cover of the drug delivery device of FIG. 29 . FIG. 18 is a top perspective view of a cassette body of the drug delivery device of FIG. 17. FIG. 32 is a bottom perspective view of the cassette body of the drug delivery device of FIG. 31 . FIG. 18 is a top perspective view of the cap of the drug delivery device of FIG. 17. 34 is a cross-sectional view taken along line 34-34 of FIG. 33. FIG. 18 is a perspective view of a retainer of the drug delivery device of FIG. 17 . 18 is a cross-sectional view of the upper housing shell of the drug delivery device of FIG. 17. FIG. 18 is a perspective view of a lower housing shell of the drug delivery device of FIG. 17 . 38 is a cross-sectional view taken along line 38-38 of FIG. 37. FIG. 18 is a cross-sectional view of the drug delivery device of FIG. 17, showing the injection position of the device. FIG. 18 is a partial cross-sectional view of the drug delivery system of FIG. 17. FIG. 18 is a cross-sectional view of the drug delivery system of FIG. 17.

Corresponding reference numerals indicate corresponding parts throughout the several views. The examples described herein illustrate exemplary aspects of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any manner.

The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the invention.

For purposes of the following description, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "side", "length" and derivatives thereof will be relevant to the present invention when oriented in the drawings. However, it should be understood that the present invention may assume various alternative modifications, except where expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

1A-10, a drug delivery device 10 according to one aspect of the present invention includes a first subassembly 12, a second subassembly 14, and a syringe assembly 16. The first subassembly 12 includes a cap 18 having an outer portion 20, a needle cover 22, a syringe holder 24, a cassette body 26, and a lower housing shell 28. The second subassembly 14 includes a drive assembly 40, a motor body 42, a lever actuation member 44, and an upper housing shell 46. The syringe assembly 16 is received by the syringe holder 24 and includes a barrel 52, a stopper 54, a cannula 56, and a rigid needle shield (RNS) 58. Although an RNS is utilized, other suitable needle shield configurations may be utilized. The lower housing shell 28, the cassette body 26, and the upper housing shell 46 generally form a housing for receiving various components of the device 10, although other suitable housing configurations may be utilized. As discussed in more detail below, the first subassembly 12 and the second subassembly 14 are secured together during assembly by a locking clip 64, although other suitable configurations may be utilized. The drug delivery device 10 may be an auto-injector, although the features described herein may be incorporated into other suitable drug delivery devices.

The drug delivery device 10 is configured to automatically deliver a dose of drug from the syringe assembly 16 to a patient upon actuation of the device 10. More specifically, actuation of the drug delivery device 10 causes the drive assembly 40 to engage the stopper 54 of the syringe assembly 16, displace the syringe assembly 16 so that the cannula 56 pierces the patient's skin, and displace the stopper 54 within the barrel 52 of the syringe assembly 16 to deliver the drug within the barrel 52. The drug delivery device 10 includes a storage position (FIGS. 1A and 2A), a pre-use position (FIGS. 1B and 2B), an actuated position (FIGS. 3 and 4), an injection position (FIGS. 5 and 6), and a post-use position (FIGS. 7 and 8). As discussed in more detail below, the needle cover 22 is configured to shield the cannula 56 of the syringe assembly 16 from the patient when the device 10 is in the pre-use and post-use positions. In particular, the needle cover 22 is movable between a pre-use position, an activated position, and a post-use position, and the spring 68 biases the needle cover 22 toward the pre-use position and the post-use position. The spring 68 is disposed between the needle cover 22 and the syringe holder 24, although other suitable configurations may be utilized. The lever actuating member 44 is movable between a locked position, in which movement of the drive assembly 40 is prevented, and a released position, in which movement of the drive assembly 40 is permitted. More specifically, the lever actuating member 44 is rotatable about a rotation axis 70 between the locked and released positions. When the lever actuating member 44 is in the locked position, the lever actuating member 44 engages the motor body 42 and the drive assembly 40, preventing movement of the drive assembly 40. When the lever actuating member 44 is in the released position, the lever actuating member 44 is disengaged from the motor body 42, thereby allowing movement of the drive assembly 40 toward the syringe assembly 16. The axis of rotation 70 of the lever actuating member 44 extends perpendicular to the longitudinal axis of the device 10, although other suitable configurations may be utilized.

1-10, the drive assembly 40 includes a plunger body 80 having a plunger rod portion 82 and a drive member 84. The plunger body 80 has a pre-use position (FIG. 2B) prior to movement of the plunger body 80, an injection position (FIG. 6) in which the plunger body 80 moves the stopper 54 within the barrel 52, and a post-use position (FIG. 8) in which movement of the plunger body 80 has stopped. The drive member 84 is a compression spring received within a drive opening 86 defined by the plunger body 80, although other suitable drive members may be utilized including, but not limited to, compressed gas, electric motors, hydraulics, other types of springs, and the like. The drive member 84 engages the plunger body 80 and the motor body 42 to bias the plunger body 80 in a direction extending from the second subassembly 14 toward the first subassembly 12. The plunger body 80 defines a lever opening 88 that receives the lever actuating member 44 and defines the axis of rotation 70 of the lever actuating member 44. The lever actuating member 44 prevents movement of the plunger body 80 by engagement of the lever actuating member 44 with the motor body 42 when the lever actuating member 44 is in the locked position. Upon rotation of the lever actuating member 44 from the locked position to the released position, the lever actuating member 44 is disengaged from the motor body 42, thereby allowing the drive member 84 to move the plunger body 80 and the plunger rod portion 82 toward the first subassembly 12. The plunger rod portion 82 and the drive member 84 are spaced apart and parallel to one another and extend longitudinally of the device 10.

The drive assembly 40 further includes a spring guide member 90 secured to the upper housing shell 46 and received within the drive opening 86 of the plunger body 80. The drive member 84 is received by the spring guide member 90 such that the drive member 84 is disposed between the plunger body 80 and the spring guide member 90. The drive assembly 40 also includes a plunger rod cover 92 that receives the plunger rod portion 82 of the plunger body 80. The plunger rod cover 92 is configured to guide the insertion of the plunger rod portion 82 into the barrel 52 of the syringe assembly 16 and to engage the stopper 54 of the syringe assembly 16 to dispense the medicament from the barrel 52 of the syringe assembly 16. The plunger rod cover 92 and the plunger rod portion 82 may be two separate parts or may be integrally formed as a single part.

The plunger body 80 of the drive assembly 40 also includes an audible indicator member 94 configured to provide an audible indication to the user when the device 10 transitions to the post-use position. As discussed in more detail below, the audible indicator member 94 is configured to engage one or more ribs 96 of the cassette body 26 when the device 10 is in the injection position, thereby deflecting the audible indicator member 94. When the drug delivery device 10 transitions from the injection position to the post-use position, the audible indicator member 94 disengages from the rib 96(s) of the cassette body 26 and contacts the lower housing shell 28 to provide an audible click, although the audible indicator member 94 could also contact other suitable portions of the device 10 to provide an audible indication.

1A-2B, in the storage position, the cap 18 is secured to the lower housing shell 28 and engaged to the needle cover 22. Movement of the needle cover 22 from the pre-use position to the actuated position causes engagement between the needle cover 22 and the lever actuating member 44, thereby actuating the drive assembly 40. After grasping the outer portion 20 to remove the cap 18, the needle cover 22 can be moved from the pre-use position to the actuated position by pressing the needle cover 22 against the patient's skin surface and pressing the device 10 axially against the skin surface. As described in more detail below, the engagement between the cap 18 and the needle cover 22 prevents the needle cover 22 from moving into engagement with the lever actuating member 44. Thus, removal of the cap 18 from the device 10 allows actuation of the device 10. As shown in FIGS. 1B and 2B, removal of cap 18 from device 10 also removes RNS 58 from syringe barrel 52, thereby exposing cannula 56, which is still received within needle cover 22 in the pre-use position of device 10. Cap 18 may include one or more components received within outer portion 20 to facilitate removal of RNS 58.

3 and 4, in the actuated position, the cap 18 is removed and the needle cover 22 is placed in the actuated position by engaging the patient's skin surface, which moves the needle cover 22 further within the device 10 toward the second subassembly 14. When the needle cover 22 has moved a sufficient distance within the device 10, a portion of the needle cover 22 engages the lever actuating member 44, which rotates the lever actuating member 44 about the axis of rotation 70 from the locked position to the released position.

5 and 6, in the injection position, the lever actuation member 44 is in a release position, which allows the plunger body 80 of the drive assembly 40 to move toward the first subassembly 12, such that the plunger body 80 or plunger rod cover 92 engages the stopper of the syringe assembly 16. The initial engagement of the drive assembly 40 with the syringe assembly 16 moves the syringe assembly 16 and the syringe holder 24 relative to the cassette body 26 within the device 10 until the syringe holder 24 abuts against a stop 102 defined by the cassette body 26. During this initial movement of the syringe assembly 16 and the syringe holder 24, with the needle cover 22 pressed against the patient's skin surface, the cannula 56 of the syringe assembly 16 extends beyond the needle cover 22 and pierces the patient's skin surface. Further movement of the plunger body 80, driven by the drive member 84, moves the stopper 54 relative to the barrel 52 of the syringe assembly 16, dispensing the medication from the barrel 52 of the syringe assembly 16, through the cannula 56, and to the patient. The plunger body 80 will continue to move until the stopper 54 bottoms out on the barrel 52 of the syringe assembly 16. When the stopper 54 bottoms out, or just before it bottoms out, the audible indicator member 94 disengages from the rib 96(s) of the cassette body 26 and nearly simultaneously contacts the lower housing shell 28 to provide an audible indication to the patient that a dose of medication has been delivered. In addition to the audible indication, the drug delivery device 10 provides one or more visual indications to inform the patient of the status of the device 10. In particular, the cassette body 26 may be formed from a transparent material to allow visual confirmation of movement of the stopper 54 and/or other visual indicators provided by the drive assembly 40, the syringe holder 24, and/or the syringe assembly 16. The lower housing shell 28 also defines an indicator opening 104 that provides a visual indication that the plunger body 80 is in a final position and a dose of medication has been delivered. The visual indicator may utilize contrasting colors, symbols, patterns, or any other suitable visual indication to indicate various states of the device.

7, 8, 11A, 11B, and 12, when the needle cover 22 is removed from the patient's skin surface in the post-use position, the needle cover 22 extends to the post-use position to shield the cannula 56. As shown more clearly in FIG. 11B, the cassette body 26 includes at least one locking arm 106 and the needle cover 22 includes at least one locking projection 108, although other suitable configurations may be utilized. The locking arm 106 of the cassette body 26 engages with the locking projection 108 of the needle cover 22 to prevent any further use of the device 10 and to prevent exposure of the cannula 56 of the syringe assembly 16. During the transition of the device 10 from the injection position to the post-use position, the locking arm 106 of the cassette body 26 flexes to allow the locking projection 108 of the needle cover 22 to pass through the cassette body 26, and the locking arm 106 returns to its original position to prevent movement of the needle cover 22 back to the pre-use and actuated position. In the pre-use position of the needle cover 22, a portion of the needle cover 22 engages with a cover stop 110 of the syringe holder 24 to limit axial movement of the needle cover 22 in a direction extending from the second subassembly 14 toward the first subassembly 12. After use of the device 10, the syringe holder 24 is displaced within the cassette body 26 relative to the needle cover 22, which allows the needle cover 22 to extend to a post-use position when the patient removes the needle cover 22 from the skin surface. As shown in FIG. 12, the needle cover 22 will move to the post-use position when the needle cover 22 is removed from the skin surface of the patient, regardless of the position of the stopper 54 in the barrel 52 of the syringe assembly 16. Thus, if the patient removes the needle cover 22 from the skin surface after only a portion of the dose of the drug has been delivered, the needle cover 22 will still move to the post-use position and prevent further use of the device 10.

1-8 and 12-16, as described above, the plunger body 80 of the drive assembly 40 includes an audible indicator member 94 configured to provide an audible indication of the transition of the plunger body 80 from the injection position to the post-use position. The audible indication may be a click, a knock, a ring, or any other suitable audible and/or tactile indication. The audible indicator member 94 has a biased position (FIG. 6), an unbiased position (FIGS. 2B and 4), and a released position (FIG. 8) in which the audible indicator member 94 engages a portion of the cassette body 26, although the audible indicator member 94 could also engage other portions of the device 10 to bias the audible indicator member 94. The audible indicator member 94 is disposed in the biased position when the plunger body 80 is in the injection position (FIG. 6) and in the released position when the plunger body 80 is in the post-use position (FIG. 8). Movement of the audible indicator member 94 from the biased position to the released position provides an audible indication. As shown in FIG. 2B, the audible indicator member 94 is disposed in the unbiased position when the plunger body 80 is in the pre-use position.

As described above, the cassette body 26, the lower housing shell 28, and the upper housing shell 46 may form a housing for the device 10, with the upper housing shell 46 abutting the lower housing shell 28, which receives the cassette body 26. The audible indicator member 94 engages with a portion of the lower housing shell 28 to provide an audible indication. More specifically, as shown more clearly in FIG. 14, the lower housing shell 28 includes an indicator platform 202. The audible indicator member 94 engages with the indicator platform 202 to provide an audible indication, although the audible indicator member 94 could engage with other portions of the device 10 to provide an audible indication.

1-8 and 12-16, the cassette body 26 includes at least one rib 96 extending longitudinally of the device 10. As shown in FIG. 15, the cassette body 26 includes two ribs 96. The audible indicator member 94 engages with the rib 96 to move the audible indicator member 94 from the unbiased position to the biased position. The audible indicator member 94 disengages from the rib 96 to move the audible indicator member 94 from the biased position to the released position, providing an audible indication. In particular, upon actuation of the device 10, the audible indicator member 94 moves from the unbiased position shown in FIG. 4 to the biased position shown in FIG. 6 as the plunger body 80 moves relative to the motor body 42, such that the audible indicator member 94 engages with the rib 96, deflecting the audible indicator member 94 and thereby moving the audible indicator member 94 to the biased position. The audible indicator member 94 will continue to slide along the rib 96 until the audible indicator member 94 reaches the end of the rib 96. After disengaging from the rib 96, the audible indicator member 94 transitions to a released position and contacts an indicator platform 202 to provide an audible indication. The audible indicator member 94 may provide an audible indication just before the stopper 54 bottoms out on the barrel 52, however, the audible indicator member 94 may provide an audible indication approximately simultaneously with the stopper 54 bottoming out, or may delay the audible indication for a predetermined time after completion of delivery of the dose of drug. The rib 96 includes a ramp 204 configured to transition the audible indicator member 94 from the unbiased position to the biased position. The ramp 204 provides a smooth transition from the unbiased position to the biased position. Although the rib 96 extends only a portion of the length of the cassette body 26, other suitable configurations may be utilized. The audible indicator member 94 is formed integrally with the plunger body 80 and moves with the plunger body 80, however, the audible indicator member 94 can be formed separately from the plunger body 80.

13, the audible indicator member 94 is configured to limit movement of the syringe holder 24 when the plunger body 80 is in the pre-use position. As described above, the lever actuation member 44 prevents movement of the plunger body 80. The syringe holder 24 is movable relative to the cassette body 26. The audible indicator member 94 engages at least one arm 210 of the syringe holder 24 to prevent movement of the syringe holder 24 during movement of the device 10 in the pre-use position or during removal of the cap 18. The arms 210 (multiple possible arms) extend radially outward from the syringe holder 24, and a portion of the audible indicator member 94 is disposed between the arms 210 (multiple possible arms) of the syringe holder 24, such that movement of the syringe holder 24 in a direction extending from the second subassembly 14 to the first subassembly 12 causes at least one of the arms 210 (multiple possible arms) to engage the audible indicator member 94 and limit further movement of the syringe holder 24.

2B, 6, 8, and 16, the device 10 also includes a visual indicator member 220 configured to provide a visual indication of the transition of the plunger body 80 from the injection position (FIG. 6) to the post-use position (FIG. 8). The visual indicator member 220 is viewable through an indicator opening 104 defined by the lower housing shell 28. The visual indicator member 220 is integrally formed with the plunger body 80 and spaced apart from the audible indicator member 94, although other suitable configurations may be utilized. As noted above, the visual indicator member 220 may utilize contrasting colors, symbols, patterns, or any other suitable visual indications to indicate various states of the device.

Referring to Figures 17-41, a drug delivery device 300 according to a further aspect of the present invention is shown. The drug delivery device 300 is similar to the drug delivery device 10 shown in Figures 1A-16, with certain differences being described in detail below. The drug delivery device 300 includes, among other components, a motor body 302, a plunger body 304, a plunger rod portion 306, a lever actuating member 308, a syringe holder 310, a needle cover 312, a cassette body 314, a cap 316, a retainer 318, an upper housing shell 320, and a lower housing shell 322.

17-20, the motor body 302 is similar to the motor body 42 of FIGS. 1A-16 and functions similarly, but further includes a longitudinal groove 324, a reinforcing rib 326(s), and a cassette clip 328(s). The longitudinal groove 324 is configured to receive a molded parting line of the plunger body 304 and ensure smooth sliding between the motor body 302 and the plunger body 304. The reinforcing rib 326(s) provide additional support to the pair of arms 260 of the motor body 302. The cassette clip 328(s) are received by an opening 330 defined by the cassette body 314 to secure the motor body 302 to the cassette body 314, which will be described in more detail below. The cassette clip(s) 328 include an angled surface 332 and a flat surface 334 that are configured to allow insertion of the cassette clip(s) 328 into the opening(s) 330 of the cassette body 314, but prevent easy removal of the cassette clip(s) 328 once inserted into the opening 330 of the cassette body 314. A bottom surface 336 of the motor body 302 includes a chamfered portion 338 to aid in assembly of the device 300.

18 and 21-24, the plunger body 304 is formed separately from the plunger rod portion 306, rather than being integrally formed. Additionally, the device 300 does not include a plunger rod cover 92. The plunger body 304 defines an opening 340 that receives the plunger rod clip 342 of the plunger rod portion 306. The plunger rod clip 342 is barb-shaped and configured to be inserted into the opening 340 of the plunger body 304 but not easily removed from the opening 340, although other suitable shapes and configurations may be utilized. The plunger rod clip 342 defines a central opening 344 that compresses the plunger rod clip 342 when inserted into the opening 340 of the plunger body 304 and allows the plunger rod clip 342 to expand to its original shape when received within the plunger body 304. The plunger rod portion 306 includes a plunger body stop 346(s) and a biasing member 348. The plunger body stop 346(s), which may be one or more protrusions, contacts the plunger body 304 when the plunger rod clip 342 is inserted into the opening 340 of the plunger body 304. The biasing member 348 engages the plunger body 304 during insertion of the plunger rod clip 342 into the opening 340 of the plunger body 304, biasing the plunger rod portion 306 toward the plunger body 304. The biasing member 348 provides additional tolerance for insertion of the plunger rod clip 342 into the opening 340 of the plunger body 304 while ensuring that there is no gap between the plunger body 304 and the plunger rod portion 306 after assembly. The biasing member 348 of the plunger rod portion 306 is annular, although other suitable shapes and configurations may be utilized.

The plunger rod portion 306 further includes a stopper interface 350 that is received by the stopper 54. The stopper interface 350 is a cross-shaped protrusion, although other suitable shapes and configurations may be utilized. The plunger rod portion 306 has a conical profile configured to reduce stress on the syringe assembly 16, although other suitable shapes may be utilized. The plunger body 304 includes a lever rib 352 that extends into the lever opening 88 of the plunger body 304. The lever rib 352 is configured to be received by the lever actuating member 308, as discussed in more detail below.

25 and 26, the lever actuating member 308 is similar to the lever actuating member 44 described above and shown in FIGS. 1A-16 and functions similarly. However, the lever actuating member 308 defines a groove 354 in the pivot 70 that receives the lever rib 352 of the plunger body 304. The engagement between the groove 354 and the lever rib 352 prevents relative lateral movement between the plunger body 304 and the lever actuating member 308. The needle cover contact surface 142 of the lever actuating member 308 includes a larger surface area as compared to the needle cover contact surface 142 of the lever actuating member 44 of FIGS. 1A-16.

27 and 28, the syringe holder 310 is similar to the syringe holder 24 of FIGS. 1A-16 and functions similarly. However, the syringe holder 310 further includes a number of ribs 356 extending circumferentially around the syringe holder 310. The number of ribs engages the spring 68. The locking ring 220 of the syringe holder 310 further includes a number of projections 358 extending radially inward. The number of projections 358 engage the syringe assembly 16 to eliminate any gap between the outer surface of the syringe assembly 16 and the syringe holder 310. The number of projections 358 are elastomeric and may collapse when the syringe assembly 16 is received within the syringe holder 310.

Referring to Figures 29 and 30, the needle cover 312 is similar to the needle cover 22 of Figures 1A-16 and functions similarly. The needle cover 312 includes spring ribs 360 that engage the springs 68 to retain the springs 68 between the needle cover 312 and the syringe holder 310. The needle cover 312 also includes cassette ribs 362(s) to guide movement of the needle cover 312 relative to the cassette body 314.

31, 32, 40, and 41, the cassette body 314 is similar to the cassette body 26 of FIGS. 1A-16 and functions similarly. As described above, the cassette body 314 includes openings 330(s) that receive the cassette clip(s) 328(s) of the motor body 302. The cassette body 314 includes needle cover clip(s) 364 that engage with clip surface(s) 366(s) of the needle cover 312. The clip surface(s) 366(s) of the needle cover 312 are planar, although other suitable shapes and configurations may be utilized. The needle cover clip(s) 364 are configured to limit axial movement of the needle cover 312 relative to the cassette body 314. The cassette body 314 further includes motor body rib(s) 368 and upper housing shell rib 370 configured to engage corresponding portions of the motor body 302 and upper housing shell 320 to aid in assembly of the device 300. The cassette body 314 also includes syringe holder stop(s) 372 configured to engage a portion of the syringe holder 310 to limit axial movement of the syringe holder 310 relative to the cassette body 314. Although not shown in FIG. 40, the locking clip 64 may also be utilized with the drug delivery device 300.

33-38, cap 316 is similar to and functions similarly to cap 18 described above and shown in FIGS. 1A-16. Cap 316 includes protrusions 374(s) that are received by cap openings 376(s) defined by needle cover 312, which are disposed at 90 degrees relative to the position of those elements of cap 18 in FIGS. 1A-16. Protrusions 374(s) of cap 316 are configured to engage needle cover 312 upon movement of needle cover 312 from a pre-use position to an activated position. For example, when device 300 is in the storage position and cap 316 is secured to lower housing shell 322, if the device is dropped or impacted in a manner that applies force to needle cover 312, lever actuation member 308, and/or other components, protrusion 374(s) will limit movement of needle cover 312, which will prevent any unintended actuation of device 300. Cap 316 further includes retainer clip 378 and rib 380 that engage with wing(s) 382 of retainer 318. Retainer clip(s) 378(s) and rib(s) 380 secure retainer 318 to cap 316 and prevent movement or wobble of retainer 318 relative to cap 316. Retainer 318 is configured to dislodge RNS 58 when cap 316 is removed from lower housing shell 322. The cap 316 includes lower housing shell clip(s) 384 that engage with the lower housing shell 322 to secure the cap 316 to the lower housing shell 322. The upper housing shell 320 and the lower housing shell 322 are similar to and function similarly to the upper housing shell 46 and the lower housing shell 28 described above and shown in FIGS. 1A-16. However, the lower housing shell 322 has a cap interface 386 for receiving the lower housing shell clip 384 of the cap 316.

Referring to FIG. 39, the drug delivery device 300 is shown in the injection position. The injection depth of the cannula 56 is determined by the contact between the syringe holder 310 and the cassette body 314 at point X, and the contact between the needle cover 312 and the syringe holder 310 at point Y.

39, the drug delivery device 300 includes an audible indicator member 388, which is similar and functions similarly to the audible indicator member 94 described above and shown in FIGS. 1A-16. Similar to the audible indicator member 94 described above, the audible indicator member 388 of the drug delivery device 300 is configured to provide an audible indication to a user when the device 300 transitions to a post-use position. The audible indicator member 388 is configured to engage with a rib 390(s) of the cassette body 314 when the device 300 is in an injection position, thereby deflecting the audible indicator member 388. The audible indicator member 388 disengages from the rib 390(s) of the cassette body 314 and contacts the lower housing shell 322 to provide an audible click when the drug delivery device 300 transitions from the injection position to a post-use position. However, the distal ends 392 of the ribs 390(s) of the cassette body 314 are angled rearward toward the upper housing shell 320, which beneficially provides a larger audible click compared to the arrangement of the ribs 96(s) of the cassette body 26 described above in connection with Figures 1A-16.

In one aspect or embodiment, the angle Z of the distal end 392 of the rib 390(s) of the cassette body 314 relative to a plane extending perpendicular to the longitudinal axis of the device 300 is greater than 5 degrees. In one aspect or embodiment, the angle Z of the distal end 392 of the rib 390(s) is greater than 10 degrees. In one aspect or embodiment, the angle Z of the distal end 392 is 25 degrees.

Elements of one disclosed embodiment may be combined with elements of one or more other disclosed embodiments to form different combinations, all of which are considered to be within the scope of the present invention.

While this disclosure has been described as having an exemplary design, the disclosure may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the scope of the appended claims.

Claims (13)

A drug delivery device (10), comprising:
A housing (26, 28, 46);
a syringe assembly (16) including a barrel (52), a stopper (54), and a cannula (56), at least a portion of the syringe assembly (16) disposed within the housing (26, 28, 46);
a drive assembly (40) including a plunger body (80) configured to move the stopper (54) within the barrel (52) upon actuation of the drive assembly (40), at least a portion of the drive assembly (40) being disposed within the housing (26, 28, 46), the plunger body (80) having a pre-use position prior to movement of the plunger body (80), an injection position in which the plunger body (80) moves the stopper (54) within the barrel (52), and a post-use position in which movement of the plunger body (80) has stopped;
an audible indicator member (94 , 388 ) connected to said plunger body (80);
The housing (26, 28, 46) includes a rib (96 , 390 ) extending longitudinally of the device (10), the rib (96 , 390 ) having an inclined surface (204) at a first end and a distal end (392) opposite the first end, the distal end (392) inclined rearwardly toward the first end at an angle (Z) of about 5 degrees to about 25 degrees relative to a plane extending perpendicular to a longitudinal axis of the device (10), the audible indicator member (94 , 388 ) engaging the rib (96 , 390 ) when the plunger body (80) is in the injection position to bias the audible indicator member (94 , 388 ) from an unbiased position to a biased position, and ) disengages from said ribs (96 , 390 ) and contacts a portion of said housing (28) when said plunger body (80) reaches a post-use position to provide an audible indication of transition of said plunger body (80) from said injection position to said post-use position. 2. The drug delivery device (10) of claim 1, wherein the audible indicator member (94, 388) has a released position, the audible indicator member (94 , 388 ) being disposed in the biased position when the plunger body (80) is in the injection position, and the audible indicator member (94 , 388 ) being disposed in the released position when the plunger body (80) is in the post- use position. 3. The drug delivery device (10) of claim 2, wherein the audible indicator member (94 , 388 ) is disposed in the unbiased position when the plunger body (80) is in the pre-use position. 4. The drug delivery device (10) of claim 1, wherein the housing (26, 28, 46) includes a lower housing shell (28), an upper housing shell (46), and a cassette body (26) received by the lower housing shell (28), the lower housing shell (28) including an indicator platform (202), and the audible indicator member (94 , 388 ) engages with the indicator platform (202) to provide an audible indication. 2. The drug delivery device (10) of claim 1, wherein the housing (26, 28, 46) includes a lower housing shell (28), an upper housing shell (46), and a cassette body (26) received by the lower housing shell (28), the cassette body (26) including the ribs (96 , 390 ). 6. The drug delivery device (10) of claim 1, wherein the ramp (204) is configured to transition the audible indicator member (94 , 388 ) from the unbiased position to the biased position. 7. A drug delivery device (10) according to claim 5 or 6, characterized in that the ribs (96 , 390 ) extend only part of the length of the cassette body (26). A drug delivery device (10) as claimed in any one of claims 1 to 7, characterized in that the audible indicator member (94 , 388 ) is integrally formed with the plunger body (80). The drug delivery device (10) of any one of claims 1-8, further comprising a visual indicator member (220) configured to provide a visual indication of the transition of the plunger body (80) from the injection position to the post-use position. The drug delivery device (10) of claim 9, characterized in that when the plunger body (80) is in the post-use position, the visual indicator member (220) is visible through an indicator opening (104) defined by the housing (26, 28, 46). The drug delivery device (10) of claim 10, wherein the housing (26, 28, 46) includes a lower housing shell (28), the lower housing shell (28) defining the indicator opening (104). 11. The drug delivery device (10) of claim 10, wherein the visual indicator member (220) is integrally formed with the plunger body (80), and the visual indicator member (220) is spaced from the audible indicator member (94 , 388 ). 13. The drug delivery device (10) of claim 1, further comprising a syringe holder (24) movable relative to the housing (26, 28, 46), and wherein the audible indicator member (94 , 388 ) is configured to limit movement of the syringe holder (24) when the plunger body (80) is in the pre-use position.

Images